BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇺🇸 United States

    PRO-TECT TRAUMA PAK

    K Number: K941789 · Decision Jan 12, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    79
    Applicant Total
    2
    Review Days
    276

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    Basic Information

    Device Name
    PRO-TECT TRAUMA PAK
    K Number
    K941789
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pro-Tect Medical Products, Inc.
    Date Received
    April 11, 1994
    Decision Date
    January 12, 1995
    Product Code
    MGP
    Advisory Committee
    Unknown
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MGP Dressing, Wound And Burn, Occlusive

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    Other Clearances by Pro-Tect Medical Products, Inc.

    K Number Device Name
    K941790 PRO-TECT SAFETY DRESSING